I. Antecedentes históricos
4) El Reglamento 2157/2001 de la Societas Europaea (SE)
A64-1. Sponsor Employer Work Address Post Code Telephone Fax Mobile Work Email Lancaster University
Division of Clinical Psychology Faculty of Health and Medicine Furness College, Lancaster University LA1 4YG
01524 592858
A64. Details of research sponsor(s)
Lead Sponsor
Status: NHS or HSC care organisation
Academic
Pharmaceutical industry Medical device industry Local Authority
Other social care provider (including voluntary sector or private organisation)
Other
Commercial status: Non- Commercial
If Other, please specify: Lancaster University
Contact person
Name of organisation Lancaster University Research Support Office
Is the sponsor based outside the UK?
Yes No
Under the Research Governance Framework for Health and Social Care, a sponsor outside the UK must appoint a legal representative established in the UK. Please consult the guidance notes.
Given name Family name Address Town/city Post code Country Telephone Fax E-mail Diane Hopkins
Research and Contracts Support Office, B Floor, Bowland Main, Lancaster University Lancaster
LA1 4YW
UNITED KINGDOM 01524 592838
A65. Has external funding for the research been secured?
Funding secured from one or more funders
External funding application to one or more funders in progress No application for external funding will be made
What type of research project is this? Standalone project
Project that is part of a programme grant Project that is part of a Centre grant
Project that is part of a fellowship/ personal award/ research training award Other
Other – please state:
A69-1. How long do you expect the study to last in the UK?
Planned start date: 24/10/2016 Planned end date: 31/05/2017 Total duration:
Years: 0 Months: 7 Days: 8
A71-1. Is this study?
Single centre Multicentre
A66. Has responsibility for any specific research activities or procedures been delegated to a subcontractor (other than a co-sponsor listed in A64-1) ? Please give details of subcontractors if applicable.
Yes No
Name of Research Ethics Committee or ethics authority: Liverpool East NRES Committee Decision
and date taken: Unethical Favourable Opinion 18/08/2016
Research ethics committee reference number: 16/NW/0613
Name of Research Ethics Committee or ethics authority: Essex NRES Committee
Decision and date taken: Provisional Opinion 13/10/2016
Research ethics committee reference number: 16/EE/0441
A67. Has this or a similar application been previously rejected by a Research Ethics Committee in the UK or another country?
Yes No
If Yes, please give details of each rejected application:
Please provide a copy of the unfavourable opinion letter(s). You should explain in your answer to question A6-2 how the reasons for the unfavourable opinion have been addressed in this application.
A71-2. Where will the research take place? (Tick as appropriate)
England Scotland Wales
Northern Ireland
Other countries in European Economic Area
Total UK sites in study 1
Does this trial involve countries outside the EU?
Yes No
A73-1. Will potential participants be identified through any organisations other than the research sites listed above?
Yes No
A73-2. If yes, will any of these organisations be NHS organisations?
Yes No
If yes, details should be given in Part C.
A72. Which organisations in the UK will host the research?Please indicate the type of organisation by ticking the box and give approximate numbers if known:
NHS organisations in England NHS organisations in Wales NHS organisations in Scotland HSC organisations in Northern Ireland GP practices in England
GP practices in Wales GP practices in Scotland GP practices in Northern Ireland
Joint health and social care agencies (eg community mental health teams)
Local authorities Phase 1 trial units Prison establishments Probation areas
Independent (private or voluntary sector) organisations
Educational establishments Independent research units Other (give details)
1
A76-1. What arrangements will be made for insurance and/or indemnity to meet the potential legal liability of the sponsor(s) for harm to participants arising from the management of the research? Please tick box(es) as applicable. Note: Where a NHS organisation has agreed to act as sponsor or co-sponsor, indemnity is provided through NHS schemes. Indicate if this applies (there is no need to provide documentary evidence). For all other sponsors, please describe the arrangements and provide evidence.
NHS indemnity scheme will apply (NHS sponsors only)
Other insurance or indemnity arrangements will apply (give details below)
Lancaster University legal liability cover will apply.
A76-3. What arrangements will be made for insurance and/ or indemnity to meet the potential legal liability of investigators/collaborators arising from harm to participants in the conduct of the research?
Note: Where the participants are NHS patients, indemnity is provided through the NHS schemes or through professional indemnity. Indicate if this applies to the whole study (there is no need to provide documentary evidence). Where non-NHS sites are to be included in the research, including private practices, please describe the arrangements which will be made at these sites and provide evidence.
NHS indemnity scheme or professional indemnity will apply (participants recruited at NHS sites only)
Research includes non-NHS sites (give details of insurance/ indemnity arrangements for these sites below)
Lancaster University legal liability cover will apply.
A74. What arrangements are in place for monitoring and auditing the conduct of the research?
The Lancaster University research team will monitor and audit the conduct of the research through regular supervision of the project and the provision of multiple draft-reads.
A76. Insurance/ indemnity to meet potential legal liabilities
Note: in this question to NHS indemnity schemes include equivalent schemes provided by Health and Social Care (HSC) in Northern Ireland
Please enclose a copy of relevant documents.
A78. Could the research lead to the development of a new product/process or the generation of intellectual property? A76-2. What arrangements will be made for insurance and/ or indemnity to meet the potential legal liability of the sponsor(s) or employer(s) for harm to participants arising from the design of the research? Please tick box(es) as applicable.
Note: Where researchers with substantive NHS employment contracts have designed the research, indemnity is provided through NHS schemes. Indicate if this applies (there is no need to provide documentary evidence). For other protocol authors (e.g. company employees, university members), please describe the arrangements and provide evidence.
NHS indemnity scheme will apply (protocol authors with NHS contracts only) Other insurance or indemnity arrangements will apply (give details below)
Lancaster University legal liability cover will apply.
Please enclose a copy of relevant documents.
PART C: Overview of research sites
Yes No Not sure
Please enter details of the host organisations (Local Authority, NHS or other) in the UK that will be responsible for the research sites. For NHS sites, the host organisation is the Trust or Health Board. Where the research site is a primary care site, e.g. GP practice, please insert the host organisation (PCT or Health Board) in the Institution row and insert the research site (e.g. GP practice) in the Department row.
Investigator
D1. Declaration by Chief Investigator
1. The information in this form is accurate to the best of my knowledge and belief and I take full responsibility for it.
2. I undertake to abide by the ethical principles underlying the Declaration of Helsinki and good practice guidelines on the proper conduct of research.
3. If the research is approved I undertake to adhere to the study protocol, the terms of the full application as approved and any conditions set out by review bodies in giving approval.
4. I undertake to notify review bodies of substantial amendments to the protocol or the terms of the approved application, and to seek a favourable opinion from the main REC before implementing the amendment.
5. I undertake to submit annual progress reports setting out the progress of the research, as required by review bodies.
6. I am aware of my responsibility to be up to date and comply with the requirements of the law and relevant guidelines relating to security and confidentiality of patient or other personal data, including the need to register when necessary with the appropriate Data Protection Officer. I understand that I am not permitted to disclose identifiable data to third parties unless the disclosure has the consent of the data subject or, in the case of patient data in England and Wales, the disclosure is covered by the terms of an approval under Section 251 of the NHS Act 2006.
7. I understand that research records/data may be subject to inspection by review bodies for audit purposes if required.
8. I understand that any personal data in this application will be held by review bodies and their operational managers and that this will be managed according to the principles established in the Data Protection Act 1998.
9. I understand that the information contained in this application, any supporting documentation and all correspondence with review bodies or their operational managers relating to the application:
Will be held by the REC (where applicable) until at least 3 years after the end of the study; and by NHS R&D offices (where the research requires NHS management permission) in accordance with the NHS Code of Practice on Records Management.
May be disclosed to the operational managers of review bodies, or the appointing authority for the REC (where applicable), in order to check that the application has been processed correctly or to investigate any complaint.
May be seen by auditors appointed to undertake accreditation of RECs (where applicable).
Will be subject to the provisions of the Freedom of Information Acts and may be disclosed in response to requests made under the Acts except where statutory exemptions apply.
May be sent by email to REC members.
10. I understand that information relating to this research, including the contact details on this application, may be held on national research information systems, and that this will be managed according to the principles established in the Data Protection Act 1998.
11. Where the research is reviewed by a REC within the UK Health Departments Research Ethics Service, I understand that the summary of this study will be published on the website of the National Research Ethics Service (NRES), together with the contact point for enquiries named below. Publication will take place no earlier than 3 months after issue of the ethics committee’s final opinion or the withdrawal of the application.
Contact point for publication(Not applicable for R&D Forms)
NRES would like to include a contact point with the published summary of the study for those wishing to seek further information. We would be grateful if you would indicate one of the contact points below.
Chief Investigator PART D: Declarations
Sponsor
Study co-ordinator Student
Other – please give details None
Access to application for training purposes (Not applicable for R&D Forms) Optional – please tick as appropriate:
I would be content for members of other RECs to have access to the information in the application in confidence for training purposes. All personal identifiers and references to sponsors, funders and research units would be removed.
Signature: ...
Print Name: Lucy Rathbone
D2. Declaration by the sponsor's representative
If there is more than one sponsor, this declaration should be signed on behalf of the co−sponsors by a representative of the lead sponsor named at A64-1.
I confirm that:
1. This research proposal has been discussed with the Chief Investigator and agreement in principle to sponsor the research is in place.
2. An appropriate process of scientific critique has demonstrated that this research proposal is worthwhile and of high scientific quality.
3. Any necessary indemnity or insurance arrangements, as described in question A76, will be in place before this research starts. Insurance or indemnity policies will be renewed for the duration of the study where necessary.
4. Arrangements will be in place before the study starts for the research team to access resources and support to deliver the research as proposed.
5. Arrangements to allocate responsibilities for the management, monitoring and reporting of the research will be in place before the research starts.
Please note: The declarations below do not form part of the application for approval above. They will not be considered by the Research Ethics Committee.
6. Where the research is reviewed by a REC within the UK Health Departments Research Ethics Service, I understand that the summary of this study will be published on the website of the National Research Ethics Service (NRES), together with the contact point for enquiries named in this application. Publication will take place no earlier than 3 months after issue of the ethics committee's final opinion or the withdrawal of the application.
7. Specifically, for submissions to the Research Ethics Committees (RECs) I declare that any and all clinical trials approved by the HRA since 30th September 2013 (as defined on IRAS categories as clinical trials of medicines, devices, combination of medicines and devices or other clinical trials) have been registered on a publically accessible register in compliance with the HRA registration requirements for the UK, or that any deferral granted by the HRA still applies.
Signature: ...
Print Name: Diane Hopkins
Post: Research Integrity and Governance Officer
Organisation: Lancaster University
D3. Declaration for student projects by academic supervisor(s)
1. I have read and approved both the research proposal and this application. I am satisfied that the scientific content of the research is satisfactory for an educational qualification at this level.
2. I undertake to fulfil the responsibilities of the supervisor for this study as set out in the Research Governance Framework for Health and Social Care.
3. I take responsibility for ensuring that this study is conducted in accordance with the ethical principles underlying the Declaration of Helsinki and good practice guidelines on the proper conduct of research, in conjunction with clinical supervisors as appropriate.
4. I take responsibility for ensuring that the applicant is up to date and complies with the requirements of the law and relevant guidelines relating to security and confidentiality of patient and other personal data, in conjunction with clinical supervisors as appropriate.
Academic supervisor 1
Signature: ...
Print Name: Dr Jane Simpson
Post: Director of Education
Organisation: Lancaster University
Date: 06/09/2016 (dd/mm/yyyy)
Academic supervisor 2
Signature: ...
Print Name: Dr Pete Greasley
Post: Teaching Fellow
Organisation: Lancaster University
Appendix A Peer Review Letter
Monday 11th July 2016
DearLucy
This letter is to confirm that your research proposal entitled:
Is self-disgust a predictor of compulsion behaviours in individuals who report obsessive- compulsive experiences?
has been anonymously peer reviewed by the research team within the Doctorate in Clinical Psychology programme, Lancaster University. The Research Director has agreed that the proposed study is suitable to proceed and submit for ethical review.
Yours sincerely
Professor Bill Sellwood
Programme and Research Director
Lancaster University Doctorate in Clinical Psychology
Faculty of Health and Medicine - Doctorate in Clinical Psychology Division of Health Research, Furness College
Appendix B
Lancaster University Sponsorship Letter
Applicant name: Lucy Rathbone Division: DHR 21 September 2016 Dear Lucy,
Re: Is self-disgust a predictor of compulsive behaviours in individuals who report obsessive- compulsive experiences?
The University of Lancaster undertakes to perform the role of sponsor in the matter of the work described in the accompanying grant application. As sponsor we assume responsibility for monitoring and enforcement of research governance. As principal investigator you will confirm that the institution’s obligations are met by ensuring that, before the research commences and during the full term of the grant, all the necessary legal and regulatory requirements are met in order to conduct the research, and all the necessary licenses and approvals have been obtained. The Institution has in place formal procedures for managing the process for obtaining any necessary or appropriate ethical approval for this grant. Full ethical approval must be in place before the research commences and should be reviewed at all relevant times during the grant.
Yours sincerely,
PP Professor Roger Pickup Associate Dean for Research
Chair Faculty of Health and Medicine Research Ethics Committee.